BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 21435278 · Received February 21, 2025

    Report

    Report Number
    9610595-2025-01900
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 24, 2025
    Report Date
    November 7, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    PMA / PMN Number
    K250432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE MOST PROBABLE CAUSE OF THE FAILURE "J-TUBE HAS FOREIGN OBJECTS." IS CAUSE TRACED TO FAILURE TO FOLLOW INSTRUCTIONS. A HISTORICAL REVIEW OF THE LAST 12 MONTHS OF COMPLAINTS WAS PERFORMED AND NO TRENDS WERE IDENTIFIED. A CAPA HISTORY REVIEW WAS PERFORMED AND CAPA-201632 WAS IDENTIFIED TO BE RELATED TO THE FAILURE "J-TUBE HAS FOREIGN OBJECTS." THE WHITE FOREIGN MATERIAL DETECTED BY INCOME INSPECTION HAS BEEN HANDLED BY OMSC CAPA-201632. ACCORDING TO PREVIOUS INVESTIGATIONS, THE USE OF PRODUCTS THAT CONTAIN SILICONE CAN CAUSE DEPOSITS OF WHITE FOREIGN MATERIAL. SILICONE IS FOR EXAMPLE INCLUDED IN SIMETHICONE, A DEFOAMING AGENT, LUBRICANTS AND SO ON. IF THE CUSTOMER USED THEM, THERE WAS RISK THAT FOREIGN MATERIAL REMAINED IN THE CHANNEL EVEN IF THE REPROCESSING WAS CONDUCTED IN ACCORDANCE WITH IFU. SIMETHICONE AND PETROLEUM/OIL/SILICONE-BASED LUBRICANTS ARE NON-WATER SOLUBLE AND THUS NOT RECOMMENDED FOR USE BY OLYMPUS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT AND UPDATE INFORMATION OF THE PREVIOUS REPORT. UPDATED FIELDS: D4 - PRIMARY UDI NUMBER, G2 - REPORT SOURCE, G4 - PMA/510(K) #, H11 CORRECTED FIELDS: E3 - OCCUPATION, H6, H11 BASED ON THE RESULTS OF THE INVESTIGATION, OLYMPUS CONFIRMED FOREIGN OBJECTS IN THE JET TUBE OF THE DEVICE, BUT THE TYPE OF THE MATERIAL OR ROOT CAUSE CANNOT BE IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE JET TUBE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692967 GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-EZ1500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown